NPR 8735.2.pdf

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NASA

Procedural Requirements

NPR 8735.2C

Effective Date: March 12, 2021

Expiration Date: March 12, 2026

COMPLIANCE IS MANDATORY FOR NASA EMPLOYEES

Hardware Quality Assurance Program Requirements for Programs and Projects

Responsible Office: Office of Safety and Mission Assurance

Table of Contents Preface P.1 Purpose P.2 Applicability P.3 Authority P.4 Applicable Documents and Forms P.5 Measurement/Verification P.6 Cancellation

Chapter 1. Overview

1.1 Introduction

1.2 Document Procedure

1.3 Tailoring

Chapter 2. Roles and Responsibilities

2.1 Chief of Safety and Mission Assurance

2.2 NASA Center Director

2.3 NASA Center SMA Director

2.4 NASA Program or Project Manager

Chapter 3. NASA Center Quality Management Systems

3.1 General

NPR 8735.2C -- TOC

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Chapter 4. Program and Project Quality Management for Mission Hardware Production

4.1 Quality Engineering (QE) and Quality Assurance (QA) Planning

4.2 Technical Standards

4.3 Design Considerations

4.4 Production Readiness

4.5 Production: Quality Assurance of Processes and Hardware

4.6 Integration and Test (I&T)

4.7 Launch and Mission Initiation Operations

Chapter 5. Supply Chain Risk Management for Mission Acquisition Items

5.1 Requirements Flow Down

5.2 Minimum Quality Management System (QMS) Requirements for External Suppliers

5.3 Counterfeit Avoidance System

5.4 Procuring "Covered Articles"

5.5 Supplier Audits and Assessments

5.6 Government-Industry Data Exchange Program (GIDEP) and NASA Advisory Risk Screening

5.7 Government Contract Quality Assurance (GCQA): Surveillance and Government Mandatory Inspection Points (GMIPs)

5.8 Federal Acquisition Regulations (FAR) References for Government Acceptance of Product

Chapter 6. Management of Quality Risks

6.1 Risk Management

6.2 Manufacturability of Non-Standard Designs

6.3 Managing Quality Nonconformances

6.4 Quality Assurance Program Stability

6.5 Supplier Process Changes

Chapter 7. Government Contract Administration - Quality Functions

7.1 Overview of Contract Administration Quality Functions

7.2 Performing Contract Administration Quality Functions

7.3 Delegation of Government Contract Quality Assurance (GCQA) Functions to Non-NASA Federal Agencies

Chapter 8. Protocols and Requirements for Delegating Quality Assurance Contract Administration Functions to Defense Contract Management Agency (DCMA)

NPR 8735.2C -- TOC

This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- TOC Page 2 of 63

Contract Management Agency (DCMA)

8.1 Delegating Quality Assurance (QA) Contract Administration to DCMA

8.2 Letter of Delegation (LOD) Development and Initial Delivery

8.3 Yearly LOD Technical and Programmatic Review

8.4 Updating LOD or a LOD's Budget within a Fiscal Year

8.5 Executing a DCMA (LOD)

Appendix A. Definitions Appendix B. Acronyms Appendix C. Considerations for Procurements of Critical Items Appendix D. Suggested Criteria for Supplier Records and Data Delivery Requirements Appendix E. Recommended Materials Review Board (MRB) Process Elements and Controls Appendix F. Recommended Life-Cycle Review (LCR) Criteria and Deliverables for Project Quality Assurance Programs Appendix G. References

NPR 8735.2C -- TOC

This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- TOC Page 3 of 63

Preface P.1 Purpose

a. The purpose of this directive is to provide the accepted standard for quality management requirements that is used, in whole or in part, to ensure the effective and consistent implementation of quality assurance programs for NASA’s missions.

b. NASA programs and projects managed in accordance with NPR 7120.5, NASA Space Flight Program and Project Management Requirements, select their unique set of quality assurance requirements from those established herein using selections based on their crew safety, technical, regulatory, programmatic objectives, and objectives imposed by other stakeholders (e.g., “do no harm”). NPR 8715.3, NASA General Safety Program Requirements, defines requirements for Safety and Mission Assurance (SMA) Technical Authority (TA) review, concurrence, and/or approval of proposed requirements tailoring. NPR 8705.4, Risk Classification for NASA Payloads suggests tailoring approaches by mission risk classification for NPR 7120.5 missions. NASA Mission Directorates may provide tailoring requirements and guidelines applicable to their missions (e.g., HEOMD-003, Crewed Deep Space Systems Certification Requirements and Standards for NASA Missions; NPR 7900.3, Aircraft Operations Management).

c. This directive is organized in mission life-cycle order so that the Mission Directorates, Mission Support Division offices (e.g., Office of Chief Engineer (OCE), Office of Safety and Mission Assurance (OSMA)), NASA Centers, and other interested parties can consistently evaluate quality program execution, maturity, and effectiveness.

d. The activities described herein are generally associated with the quality assurance discipline and depend on quality assurance subject matter expertise for successful implementation. Some of the activities and requirements herein may be intertwined with the work of other discipline areas (e.g., engineering design, materials engineering, procurement, operations), depending on how the program or project is organized, on a NASA Center’s organizational structure, or on an external supplier’s organizational structure.

e. While a program or project may adopt a particular quality assurance technique or process described herein in their quality plan, it is assumed that they will consider the intent of the requirement or technique and will apply risk-based decision making when determining when to apply that technique on a sample basis, on a 100 percent basis, or based solely on known risk considerations (e.g., quality challenges, technology challenges, supplier past performance).

f. Programs and Projects are expected to accept the use of alternate technical standards when they meet or exceed the intents and specifications of the technical standards referenced herein and when doing so is advantageous for mission success.

g. NASA research and development projects select requirements herein as needed to satisfy regulatory and “do-no-harm” stakeholders’ objectives and, when programmatically possible, to adopt requirements herein that assure technical objectives (i.e., engineering and science) are met (for additional information, see NPR 7120.8, NASA Research and Technology Program and Project Management Requirements).

h. This directive establishes the requirements used by NASA Centers to establish and maintain a

NPR 8735.2C -- Preface This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Preface Page 4 of 63 quality management system for developing, manufacturing, or processing mission hardware.

P.2 Applicability

a. This directive is applicable to NASA Headquarters and NASA Centers, including Component Facilities and Technical and Service Support Centers. This language applies to the Jet Propulsion Laboratory (a Federally-Funded Research and Development Center), other contractors, recipients of grants, cooperative agreements, or other agreements only to the extent specified or referenced in the applicable contracts, grants, or agreements.

Note: See 2.4.2 regarding Program Management Offices’ responsibilities for flowing down a collection of quality engineering, quality assurance, and quality management system (QMS) requirements that are appropriately tailored for the mission objectives and that are traceable to the requirements, herein, to non-Government entities who have been assigned project office responsibility (e.g., Federally-Funded Research and Development Centers, universities, and other non-governmental organizations).

b. In this directive, all mandatory actions (i.e., requirements) are denoted by statements containing the term “shall.” The term “may” denotes a discretionary privilege or permission, “can” denotes statements of possibility or capability, “should” denotes a good practice and is recommended but not required, “will” denotes expected outcome, and “are/is” denote descriptive material.

c. This directive does not apply to quality assurance functions related to software. See NASA-STD-8739.8, Software Assurance and Software Safety Standard, and NPR 7150.2, NASA Software Engineering Requirements, for software assurance functions.

d. This directive does not apply to quality assurance functions related to the acquisition of NASA institutional facilities or to facility maintenance managed in accordance with NPR 7120.7, NASA Information Technology and Institutional Infrastructure Program and Project Management Requirements.

e. This directive does not apply to information technology (IT) services including procurements of commercial IT equipment that is not mission hardware.

f. In this directive, all document citations are assumed to be the latest version unless otherwise noted.

g. In this directive, “Center Director” refers to the Center Directors, to the Executive Director, Headquarters Operations, and to the directors of Component Facilities and Technical and Service Support Centers.

h. The requirements enumerated in this directive are applicable to all new programs and projects that are in Formulation Phase as of or after the effective date of this directive. (See NPR 7120.5 for definitions of program phases.) Programs and projects whose quality assurance program is currently traceable to the previously published NPR 8735.2 may choose to adhere to additional requirements herein.

P.3 Authority

NPR 8735.2C -- Preface This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Preface Page 5 of 63

a. NPD 8700.1, NASA Policy for Safety and Mission Success.

b. NPD 8730.5, NASA Quality Assurance Program Policy.

P.4 Applicable Documents and Forms

a. NPR 2810.1, Security of Information Technology.

b. NPR 7120.5, NASA Space Flight Program and Project Management Requirements.

c. NPR 7900.3, Aircraft Operations Management.

d. NPR 8000.4, Agency Risk Management Procedural Requirements.

e. NPR 8735.1, Exchange of Problem Data Using NASA Advisories and the Government-Industry Data Exchange Program (GIDEP).

f. NASA-STD-5009, Nondestructive Evaluation Requirements for Fracture Critical Metallic Components.

g. NASA-STD-8739.14, NASA Fastener Procurement, Receiving Inspection, and Storage Practices for NASA Mission Hardware.

h. NASA-STD-6016, Standard Materials and Processes for Spacecraft.

i. NASA-STD-8739.1, Workmanship Standard for Staking and Conformal Coating of Printed Wiring Boards and Electronic Assemblies.

j. NASA-STD-8739.4, Crimping, Interconnecting Cables, Harnesses, and Wiring.

k. NASA-STD-8739.5, Fiber Optics Terminations, Cable Assemblies, and Installation.

l. NASA-STD-8739.6, Implementation Requirements for NASA Workmanship Standards.

m. NASA-STD-8739.10, Electrical, Electronic, and Electromechanical (EEE) Parts Assurance Standard.

n. NASA-STD-8739.12, Metrology and Calibration.

o. NASA-STD-8739.14, NASA Fastener Procurement, Receiving Inspection, and Storage Practices for NASA Mission Hardware.

p. NF 1430B, Quality Assurance.

q. NF 1431, Letter of Acceptance of Contract Administration Delegation.

r. NF 1707, Special Approvals and Affirmations of Requisitions.

s. ANSI/ESD S20.20-2014, ESD Association Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices).

t. NAS 412 Revision 1, Foreign Object Damage/Foreign Object Debris (FOD) Prevention.

NPR 8735.2C -- Preface This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Preface Page 6 of 63

u. IPC J-STD-001GS, Joint Industry Standard, Space Applications Electronic Hardware Addendum to IPC J-STD-001G Requirements for Soldered Electrical and Electronic Assemblies (Chapter 10 of IPC J-STD-001GS does not apply).

v. IPC/WHMA-A-620C-S, Space Applications Electronic Hardware Addendum to

IPC/WHMA-A-620C.

w. ISO 9001, Fifth Edition, Quality Management Systems – Requirements.

x. ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories.

y. SAE AS5553C, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.

z. SAE AS6174A, Counterfeit Materiel, Assuring Acquisition of Authentic and Conforming Materiel.

aa. SAE AS9003A, Inspection and Test Quality Systems, Requirements for Aviation, Space, and Defense Organizations.

bb. SAE AS9100D, Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations.

cc. SAE AS9110C, Quality Maintenance Systems - Aerospace - Requirements for Maintenance Organizations.

dd. SAE EIA-649-2, Configuration Management Requirements for NASA Enterprises.

ee. SAE GEIA-STD-0005-1A, Performance Standard for Aerospace and High Performance Electronic Systems Containing Lead-free Solder.

ff. SAE GEIA-STD-0005-2A, Standard for Mitigating the Effects of Tin Whiskers in Aerospace and High Performance Electronic Systems.

P.5 Measurement/Verification The Centers and the Safety and Mission Assurance (SMA) Technical Authority (TA) continually monitor for compliance with this NPR. Compliance may also be verified as part of selected life-cycle reviews and by assessments, reviews, and audits of the requirements and processes defined within this directive.

P.6 Cancellation NPR 8735.2B, Management of Government Quality Assurance Functions for NASA Contracts, dated August 12, 2013.

NPR 8735.2C -- Preface This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Preface Page 7 of 63

Chapter 1. Overview

1.1 Introduction

1.1.1 This NPR provides the accepted standard for requirements used by programs and projects to establish and execute their quality assurance (QA) programs; hereafter referred to as the Project QA program. The Project QA program applies management, quality engineering (QE), and QA practices, and technical criteria, to acquisitions, system integrations, and hardware deployments in a manner that enables the project to meet its mission objectives. The requirements are arranged in the sequence in which QE and QA activities take place within the formulation, planning and analysis, execution, verification, and risk management phases of program or project development (Chapter 4-6). Stand-alone chapters that require additional and more detailed explanation and prescription for contract administration are Chapters 7 and 8.

1.1.2 Chapter 3 defines requirements for Center quality management systems (QMSs) that are institutional in nature and provide in-house capabilities used by programs and projects for life-cycle activities named in 1.1.1 above. The definition for "institutional" provided in NPR 7120.5 applies to the above statement.

1.1.3 Appendices C through F provide guidance to programs and projects through example text and lists applicable for developing requirements for procurements and for life-cycle reviews.

1.1.4 When a requirement herein has associated procedures in the Federal Acquisition Regulation (FAR) or the NASA Federal Acquisition Regulation Supplement (NFS), those parts of the FAR and NFS are referenced for information. These references may also be used to recognize requirements traceability to regulatory objectives.

1.2 Document Procedure

Where there are conflicts between the requirements found in this directive and the technical standards in section P.4, the requirements of this directive take precedence.

1.3 Tailoring

1.3.1 NPR 8715.3 provides requirements and guidance for programs and projects that will document and seek approval for requirements tailoring and other risk management decisions. See NPR 8000.4, Risk Management Procedural Requirements, for the roles and responsibilities associated with risk acceptance.

1.3.2 For programs or projects where mission hardware development, manufacturing, or processing will occur within a NASA Center (i.e., the NASA Center is the supplier) concurrence by the Center SMA Director, or their delegate, is required for requirements tailoring that conflicts with the Center's SMA policies and/or its QMS.

1.3.3 Centers are permitted to tailor the requirements of AS9100D, Quality Management Systems - Requirements for Aviation, Space and Defense Organizations, when establishing their quality management system (see 3.1.3 herein) in order to align the QMS with the type of work performed at

NPR 8735.2C -- Chapter1 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter1 Page 8 of 63 the Center and to support actively managed programs and projects.

1.3.4 For payloads, NPR 8705.4, provides requirements and guidance to programs and projects that seek to tailor the requirements herein to meet programmatic and technical mission objectives when establishing their Project QA Plan.

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NPR 8735.2C -- Chapter1 Page 9 of 63

Chapter 2. Roles and Responsibilities

2.1 Chief of Safety and Mission Assurance

2.1.1 The Chief, SMA is responsible for:

a. Establishing the accepted standard requirements for QA for NASA programs and projects.

b. Designating a Technical Liaison to the Defense Contract Management Agency (DCMA) to:

(1) Assess DCMA’s programmatic and technical performance for assigned QA tasks, across all projects.

(2) Coordinate with the following entities to address and resolve programmatic or technical issues related to Government Contract Quality Assurance (GCQA) functions delegated to DCMA:

(a) DCMA management.

(b) NASA DCMA Center Integrators.

(c) NASA project QA personnel who are assigned the duties of delegating work to DCMA.

(d) Program-level and project-level procurement and resource authorities.

(e) OSMA.

(3) Coordinate with the entities in 2.1.1.b(2) above for generating new work delegations to DCMA, for updating statements of work for delegated tasks, and for generating annual updates to those statements of work and to their associated budgets.

2.2 NASA Center Director

2.2.1 The NASA Center Director is responsible for:

a. Providing leadership and resources for the Center’s compliance with the QMS requirements herein.

b. Providing leadership and resources for compliance with the quality data management requirements herein.

2.3 NASA Center SMA Director

2.3.1 The NASA Center SMA Director is responsible for ensuring:

(1) Center-level, cross-cutting hardware QE and QA requirements and processes are established within the Center’s QMS for hardware developed, manufactured, and/or processed for projects assigned to the Center.

(2) That leadership roles and responsibilities for Project QA program management are assigned to an individual(s) who is a subject matter expert in the quality engineering and quality assurance

NPR 8735.2C -- Chapter2 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter2 Page 10 of 63 disciplines.

(3) That quality subject matter experts are assigned leadership roles for executing the processes associated with defining and delegating GCQA functions to DCMA (see Chapter 8 herein).

(4) Programs and projects QA program formulation, management, and execution adheres to the Center’s QMS requirements and processes.

(5) That QE and QA discipline support is provided to projects including but not limited to:

(a) QE and QA subject matter experts and appropriately trained and certified QA personnel.

(b) QE and Project QA program strategies that are traceable to those defined herein.

(c) QE and QA procedures.

(d) Cross-discipline experts, as needed, within the SMA domain who provide inputs to the program or project for identifying and managing quality risks (e.g., crew-safety, reliability, software assurance).

2.4 NASA Program or Project Manager

2.4.1 NASA Program or Project Managers, hereafter referred to as Project Managers, are responsible for:

a. Establishing a Project QA program and QA program management function that addresses the requirements herein with or without tailoring in order to meet the mission success objectives within the programmatic constraints.

b. Delivering evidence of Project QA program maturity and execution at life cycle and key decision point (KDP) reviews that is commensurate with the project’s point in their life cycle. See Appendix F for recommended Life-Cycle Review (LCR) criteria and deliverables for Project QA Programs.

c. Coordinating with the Project QA program management function (see 2.4.1.a) to:

(1) Formulate and execute a Project QA program that maximizes alignment with the responsible NASA Center’s SMA policies and QMS.

(2) Define the requisite programmatic resources required for executing the Project QA Program.

(3) Facilitating cross-discipline collaborations as needed for effective strategy building, planning, QA program execution, and problem solving.

(4) Obtain insight and context about Project QA program strategies, plans, execution results, problem resolution, and risk management.

(5) Obtain quality assurance stakeholder review and concurrence for all procurement products for mission hardware including requests for proposals, contracts, task orders, and purchase orders.

Note: Engineering and quality assurance stakeholders are part of the internal Government team and their input assures that the requirements flowed to the suppliers via these procurement products are fully traceable to the Project QA Plan and the requirements herein.

NPR 8735.2C -- Chapter2 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter2 Page 11 of 63

d. Identify and manage QA risks (e.g., product or process nonconformities, supplier quality deficiencies, and technology immaturity obstacles to defining quality controls).

2.4.2 When there is no NASA Project Management Office, the NASA Program Manager is accountable for the implementation of a QA program for projects not managed by NASA and is responsible for:

a. Flowing down Project Manager responsibilities and all relevant programmatic and technical requirements herein to the non-NASA project-managing entity through contracts or other partnership agreements.

b. Ensuring responsibilities and requirements not flowed down to the non-NASA project-managing entity are implemented.

NPR 8735.2C -- Chapter2 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter2 Page 12 of 63

Chapter 3. NASA Center Quality Management Systems

3.1 General

3.1.1 As a means of installing the quality controls and verifications required herein into the daily work of NASA Centers and in order to achieve the policy of NPD 8730.5, each NASA Center Director shall implement and maintain a QMS within the Center and within those component facilities for which the Center is directly responsible for, that:

a. Is comprehensive with respect to the quality controls necessary to meet regulatory, crew safety, property preservation, and mission objectives commonly held by missions assigned to the Center.

b. Is compliant with AS9100D with exceptions and alternate equivalent approaches documented.

c. Is readily accessible by Center personnel who are responsible for adhering to the policies, procedures, and practices defined by the QMS.

d. Includes the following additional processes, procedures, and programs:

(1) Approach used for adherence to NPR 8735.1, Exchange of Problem Data Using NASA Advisories and the Government-Industry Data Exchange Program (GIDEP).

(2) Management and use of supplier audit and assessment data by:

(a) Entering supplier audit and assessment data in the https://sas.nasa.gov database.

(b) Using the data in the https://sas.nasa.gov database as a minimum for analyzing suppliers’ past performance.

(3) A counterfeit avoidance system that adheres to the following technical standards:

(a) SAE AS6174A, Counterfeit Materiel, Assuring Acquisition of Authentic and Conforming Materiel for parts and materials that are not considered to be EEE parts.

(b) AS5553C, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition, for EEE parts.

(4) Electrostatic Discharge (ESD) control in accordance with NASA-STD-8739.6, Implementation Requirements for NASA Workmanship Standards, and ANSI/ESD S20.20-2014, ESD Association Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices).

(5) Metrology and calibration in accordance with NASA-STD-8739.12, Metrology and Calibration.

(6) Fastener QA in accordance with NASA-STD-8739.14, NASA Fastener Procurement, Receiving Inspection, and Storage Practices for NASA Mission Hardware.

(7) Pb-free tin and Pb-free tin alloy control program that adheres to the requirements of 4.3.4.a herein.

NPR 8735.2C -- Chapter3 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter3 Page 13 of 63 herein.

(8) Foreign object debris controls that comply with NAS 412 Revision 1, Foreign Object Damage/Foreign Object Debris (FOD) Prevention.

(9) Engagement of the appropriate procurement officer when a Government-accepted item, with a warrantee, has been found to be defective or nonconforming (for additional information, see NFS 1846.770, Administration).

3.1.2 NASA Center Directors shall establish and maintain crosscutting quality requirements, considered to be of the institutional type, within the Center’s QMS. For additional information on the definition of institutional requirements, see NPR 7120.5.

3.1.3 Tailoring of the QMS requirements herein by NASA Centers is permitted for optimizing the QMS for the type of hardware development, manufacturing, and processing work performed at the Center. SMA Directors shall make the rationale available to second- and third-party auditors for breaks in traceability between the Center’s QMS command media and the QA requirements herein and in AS9100D. This includes use of alternate, equivalent technical standards.

3.1.4 NASA Center Directors shall annually inform the Chief, SMA, of the state of the Project QA program at their Center, including performance indicators and risks to the satisfactory implementation of QA responsibilities defined in this NPR.

NPR 8735.2C -- Chapter3 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter3 Page 14 of 63

Chapter 4. Program and Project Quality Management for Mission Hardware Production

4.1 Quality Engineering (QE) and Quality Assurance (QA)

Planning

4.1.1 Project Managers shall establish and execute the Project QA program that provides mission success assurance for the defined crew safety, technical, programmatic, regulatory, and other stakeholders’ objectives (e.g., do-no-harm) and that is commensurate with the program’s or project’s risk posture. Hereafter, these objectives will be referred to as mission success objectives.

4.1.2 The Project Managers shall develop the QA program that addresses the requirements herein and the following as a minimum:

a. For compliance with NPD 8730.5.

b. Using risk-informed selection and use of the requirements, controls, and practices, herein, that maximize conformance of hardware attributes and process attributes considered to be critical for meeting mission success objectives. See NPR 8715.3 for the roles and responsibilities associated with requirements tailoring and safety and mission assurance (SMA) technical authority (TA).

c. Personnel safety during development as well as during the mission.

d. Consideration of relevant quality specifications, controls, and verification methods when managing technology readiness and manufacturability of designs.

e. Designs and product selections that consider supplier quality and market availability risks in designs and product selections.

f. Use of appropriate FAR and NFS clauses in contracts and purchase orders that enable effective flow-down of technical requirements and execution of GCQA functions.

g. The roles and responsibilities of those who will execute the plan.

4.1.3 The Project Manager shall:

a. Document the project quality program requirements in an SMA plan (SMAP) or a document that is referenced by the SMAP (e.g., mission assurance requirements (MAR) document), hereafter referred to as the Project QA Plan.

Note: Quality requirements considered to be of the programmatic type, as defined by NPR 7120.5, are usually contained in the program- or project-specific engineering documentation and requirements of the institutional type, as defined by NPR 7120.5, are contained in the SMAP.

NPR 8735.2C -- Chapter4 This document does not bind the public, except as authorized by law or as incorporated into a contract. This document is uncontrolled when printed. Check the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov.

NPR 8735.2C -- Chapter4 Page 15 of 63

b. Provide sufficient detail and organization in project QE and QA documentation to enable contracting officers (CO) and procurement authorities to fully specify the appropriate QA requirements on procurement contracts, task orders, and purchase orders (See 5.1, Requirements Flow-Down).

c. Obtain concurrence from the Center-level SMA TA for the Project QA program requirements prior to their flow-down to suppliers.

4.1.4 Critical Items and Processes Determination. Project Managers shall:

a. Manage criticality identification by:

(1) Ensuring that the method used to identify critical items and processes are controlled, documented, and communicated to suppliers and personnel responsible for executing the project QA plan (for additional information, see Criteria for use of contract quality requirements, 48 CFR § 46.203). See Appendix A for the definition of critical.

(2) Flowing down relevant requirements to suppliers when their input is necessary for identifying critical items or processes and associated technical specifications.

(3) Considering the criticality of items and processes used in mission development activities and products (e.g., consumed materials, ground support equipment, launch operations processes, aircraft modifications and maintenance, laboratory evaluation processes, test and verification processes, repair processes).

Note 1: Criticality derives from importance with respect to achieving a mission objective (e.g., crew safety, technical (engineering or science), programmatic (cost and schedule), regulatory, other stakeholders’ (hosts’ requirements)) and may be identified incrementally over the mission life cycle.

Note 2: Disseminating the assigned hardware criticality categorization (e.g., crew-safety-critical, science-critical, regulatory-critical) to project team members and suppliers may be necessary for their understanding of risk ownership and thus context for risk-based decision making.

Note 3: It is common to classify all mission hardware as crew-safety-critical or mission-critical thereby enabling use of a single set of QA requirements for all hardware developments and acquisitions. Programs and projects are cautioned to recognize the programmatic burden of resolving quality gaps for items that have been classified as critical by default but when failing to adhere to quality requirements will not create an unacceptable mission risk. This result is likely to distract resources from more important problems.

Note 4: The strategies for determining item (i.e., hardware) or process criticality should consider: i.) system-level design to determine the relationship of item failure to a catastrophic safety outcome or to mission failure due to a quality defect, and ii.) the threat a quality defect places on the project’s resources if the item is to be redesigned, rebuilt, or replaced during development to overcome a nonconformity. Common techniques for determining hardware criticality include hazard analysis, and design and process failure

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NPR 8735.2C -- Chapter4 Page 16 of 63 determining hardware criticality include hazard analysis, and design and process failure modes, and effects analyses (FMEAs) though these alone may not be sufficient and other objective or subjective assessment criteria may be needed.

4.1.5 Quality Data and Records Management

4.1.5.1 Project Managers shall collect, organize, and analyze data to achieve the following objectives:

a. Demonstrate quality conformance.

b. Record nonconformances over the entire mission development life cycle (for additional information, see Contract administration office responsibilities, 48 CFR § 46.104(c)). Also, see 6.3, Managing Quality Nonconformances.

c. Provide efficient traceability to and identification of material, component, and subsystem configurations and quality pedigrees for rapid identification of current levels of requirements compliance and impacts from known and emerging quality problems (e.g., GIDEP alerts, counterfeit items, fraudulent material certifications, faulty designs, and qualification failures).

d. Support the version integrity of QA products such that they are consistent with the project’s configuration management (CM) plan. For additional information, see NPR 7123.1, NASA Systems Engineering Processes and Requirements, for program and project CM requirements.

4.1.6 Personnel Credentials. The Project Manager shall include requirements in the Project QA program for personnel that achieve:

a. Personnel training or certification, in accordance with, and when required by, the applicable technical standard for the work being performed (e.g., manufacturing, test, inspection), prior to performing that work (e.g., calibration, soldering, electrical harness installation, nondestructive evaluation, process witnessing, product inspection).

b. Prohibition of personnel performing QA verifications on their own work (e.g., procedures, fabrication, testing).

4.1.7 Quality Implementation Plans. The Project Manager shall include requirements in the Project QA program for development and delivery of QA implementation plans by the suppliers that:

a. Indicate how project-unique quality requirements and product, process, and verification specifications will be accommodated within or in addition to the supplier’s existing QMS. A compliance matrix is recommended for efficiently communicating the supplier’s recognition and handling of the quality requirements that have been flowed to them.

b. Communicate the intended use and sequence of manufacturing processes, tests, and inspections.

c. Communicate how the Supply Chain Risk Management requirements of Chapter 5, Supply Chain Risk Management for Mission Acquisition Items, will be met.

4.2 Technical Standards

The technical standards adopted by NASA for quality engineering and quality assurance are listed in Table 4.1. Project managers shall include these standards and the requirements therein, or alternate

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NPR 8735.2C -- Chapter4 Page 17 of 63

Table 4.1. Project managers shall include these standards and the requirements therein, or alternate equivalent technical requirements and standards in the Project QA program. These technical standards are referred to in several sections of this directive because they are relevant to a variety of product development activities (e.g., design, process development, personnel training, and quality assurance).

Table 4.1 NASA Adopted Technical Standards for Quality Engineering and Quality Assurance

Document Number Title

NASA-STD-5009 Nondestructive Evaluation Requirements for Fracture Critical Metallic Components

NASA-STD-6016 Standard Materials and Processes for Spacecraft

NASA-STD-8739.1 Workmanship Standard for Staking and Conformal Coating of Printed Wiring Boards and Electronic Assemblies

NASA-STD-8739.4 Crimping, Interconnecting Cables, Harnesses, and Wiring or IPC IPC/WHMA-A-620B-S, Space Applications Electronic Hardware Addendum to IPC/WHMA-A-620B

NASA-STD-8739.5 Fiber Optics Terminations, Cable Assemblies, and Installation

NASA-STD-8739.6 Implementation Requirements for NASA Workmanship Standards

NASA-STD-8739.10 Electrical, Electronic, and Electromechanical (EEE) Parts Assurance Standard

NASA-STD-8739.12 Metrology and Calibration

NASA-STD-8739.14 NASA Fastener Procurement, Receiving Inspection, and Storage Practices for NASA Mission Hardware

ANSI/ESD

S20.20-2014

ESD Association Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices)

IPC J-STD-001GS Joint Industry Standard, Space Applications Electronic Hardware Addendum to IPC J-STD-001G Requirements for Soldered Electrical and Electronic Assemblies (Chapter 10 of IPC J-STD-001GS does not apply)

IPC/WHMA-A-620C-S Space Applications Electronic Hardware Addendum to

IPC/WHMA-A-620C

NAS 412 Revision 1 Foreign Object Damage/Foreign Object Debris (FOD) Prevention

SAE

GEIA-STD-0005-1A

Performance Standard for Aerospace and High-Performance Electronic Systems Containing Lead-free Solder

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NPR 8735.2C -- Chapter4 Page 18 of 63

SAE

GEIA-STD-0005-2A

Standard for Mitigating the Effects of Tin Whiskers in Aerospace and High-Performance Electronic Systems

SAE AS5553C Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.

SAE AS6174A Counterfeit Materiel, Assuring Acquisition of Authentic and Conforming Materiel

4.3 Design Considerations

Using proactive quality control and quality assurance techniques is recognized to be the most impactful quality assurance strategy for meeting programmatic mission objectives and for reducing long-term technical risks presented by quality escapes and latent defects in reworked and repaired hardware. This is referred to as “building quality in.” These techniques maximize manufacturability and leverage established quality controls as an integral part of the design phase. While the QA program will not be the source of hardware or process designs directly, the QA program will apply applicable controls and assurance techniques that result in designs that transfer readily to manufacturers, where process controls can be readily specified and for which verification methods are available and perceptive of relevant defects. Examples of the types of quality controls addressed in this section for design assurance are documentation of specifications, leveraging NASA-adopted technical standards, qualification for new processes, and supply chain risk management. Quality assurance is applied in the form of reviews or assessments of engineering documentation and manufacturing processes. This section establishes the techniques to be used; however, it does not prescribe a particular level of quality assurance surveillance. All uses of quality assurance surveillance are expected to be risk-based with priority given to safety-critical hardware and process attributes (related to crew safety objectives or to Occupational Safety and Health Administration regulatory objectives).

4.3.1 Design Considerations and Technical Specifications. In the Project QA program, the Project Manager shall address the requirements in paragraphs a. and b. and the relevant requirements in the technical standards listed in Table 4.1 to ensure the design, construction, and verification specifications are defined, documented, and can be achieved with low programmatic risk. The design, construction, and verification specifications both inform, and are derived from, the design process.

a. Design, construction, and verification specifications are documented both in engineering documentation (e.g., data sheets, technical specifications, drawings, procedures) and by reference to technical standards. Design, construction, and verification specifications are used to determine product quality conformance.

b. The design, construction, and verification specifications are specified in a manner that enables their effective flow-down to work groups and suppliers within and outside of NASA in a manner that:

(1) Maximizes efficient acquisition of parts and materials.

(2) Maximizes manufacturability.

(3) Achieves reliability objectives.

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NPR 8735.2C -- Chapter4 Page 19 of 63

(4) Achieves item-quality conformance.

(5) Provides a basis for physical configuration verification.

Note: The limited scope of coverage by the technical standards listed in Table 4.1 is not intended to relieve programs, projects, developers, and manufacturers from adequately defining and identifying design, construction, and verification specifications. For new designs, materials, and manufacturing methods, quality engineering activities are expected to produce unique and technically applicable design, construction, and verification specifications when available technical standards are insufficient.

4.3.2 Retrievable Engineering Documentation. Project Managers shall ensure that personnel performing QE and QA functions have routine access to, and knowledge of, the design, construction, and verification specifications when necessary to perform their work.

4.3.3 Identify Verifications and Tests. The Project Manager shall ensure that the Project QA program includes the requirements in a. through d. for the use of fully developed tests and inspections to evaluate item and process quality conformance, both during production (i.e., in-process) and at the point of acceptance or certification (i.e., end-of-line).

a. Prior to production, the verifications (i.e., tests and inspections) that will be used to evaluate product or process conformance are documented (for additional information, see Contractor responsibilities, 48 CFR § 46.105.(b)).

b. The minimum qualification and verification requirements are specified in a manner that enables their effective flow down to work groups and suppliers within and outside of NASA.

c. Reporting requirements for verification results and data are defined including those applicable to the party responsible for performing the test or the verification (for additional information, see 48 CFR § 46.104(e)).

d. Personnel performing QE and QA functions have routine access to knowledge of the verifications and pass/fail criteria that are required when it is necessary for performing their work.

4.3.4 The Project Manager shall include the following requirements in the Project QA program:

a. Compliance with the following for control of Pb-free materials:

(1) Conformance by suppliers with the criteria of SAE-GEIA-STD-0005-1A and SAE-GEIA-STD-0005-2A using control level “2C.”

(2) Extension of Pb-free controls to non-critical items when necessary to mitigate the risk of metal whisker growth on, and liberation from, a non-critical item affecting critical item performance during a mission.

b. Fasteners and fastener supplier selection comply with NASA-STD-8739.14. See NASA-STD-8739.14 for further explanation of hardware applicability.

c. Compliance with NASA-STD-8739.12 for the following:

(1) Measurements affecting safety and mission success.

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NPR 8735.2C -- Chapter4 Page 20 of 63

(2) Calibration services providers.

4.3.5 Supplier Risk Assessment and Selection. The Project Manager shall include the following requirements in the Project QA program:

a. In addition to the requirements in NPR 8735.1, the NASA supplier assessment system (SAS;

https://sas.nasa.gov) is used for supplier prescreening. Additional supply chain risk management processes may also be used such as certified or qualified supplier lists and risk assessments based on previous or current GCQA activities. This requirement cannot be flowed down to non-NASA project offices.

b. A pre-award supplier audit, assessment, survey, or equivalent, is used to evaluate supplier risk where no prior record can be referenced in SAS or in a Government or NASA Center supplier qualification or certification system, or where the prior audit, assessment, survey or GCQA records are older than three years. This requirement cannot be flowed down to non-NASA project offices.

4.3.6 Design Risk Mitigation. The Project Manager shall address the following design review considerations in the Project QA program to identify and mitigate design specifications that create manufacturability, delivery, or performance vulnerabilities:

a. The critical design and process specifications, limits, controls, acceptance criteria, and physical attributes:

(1) Are fully defined and documented in the engineering documentation.

(2) Are addressed by engineering as being complementary across system interfaces and are complementary with planned manufacturing methods, processing methods, and test conditions.

(3) Are addressed by engineering as providing the required mission hardware reliability given the materials and manufacturing methods used, including consumed materials (e.g., gasses, soldering flux, and solvents).

(4) Remain traceable to product or process qualifications (i.e., design remains qualified with accumulation of “red line” changes to engineering documentation).

(5) Provide safety margin against unexpected…